Validation

This package features 34 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within a Medical Device organization.

This package features 29 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within an organization.

This template package features a universal IQ/OQ Protocol template that provides a ready-to-populate document to generate an IQ, OQ, or IOQ in the pharma or biotech industry.

This training package features a training presentation which provides an overview of statistical methods and how they can be utilized for validation.

This SOP package features an SOP template that provides instructions for the preparation and execution of riboflavin coverage tests in washers and tanks.

This SOP package features an SOP template that provides a step-by-step procedure and test logs for thermal mapping a pharmaceutical refrigerator.

This template package features a comprehensive outline of the information required in a User Requirements Specification for the Biotechnology, Medical Device or Pharmaceutical industries. It includes sections for process overview, design and construction, operational requirements, automation requirements, safety, acceptance and delivery, and documentation. Suggested technical content is also included throughout the template.

This training package features a training presentation which provides an overview of cleaning validation in the medical device industry.

This training package features a training presentation which provides an overview of cleaning validation in the pharmaceutical and biotech industries.

The Kymanox Feed Through Assembly is a cost effective method for inserting thermocouples into pressurized environmental chambers, such as sterilizers.

This SOP package features a comprehensive step-by-step procedure that provides instructions for the construction, installation, and operation of a feed through assembly.

This rental package provides a cost effective method for inserting thermocouples into pressurized environmental chambers, such as sterilizers.

This training package features a training presentation which provides training and quality professionals with a strong tool for training their workforce in the basics of validation master plans.

This equipment package includes everything needed to perform reliable, highly accurate temperature studies, including a laptop PC and 36 premium thermocouples.

This equipment rental package includes everything needed to perform reliable, highly accurate temperature studies, including a laptop PC, feed through assembly, and 36 premium thermocouples.

Kymanox provides experienced personnel to perform data logging services using the Kaye Validator 2000 to deliver the information that you need.

This training package features a training presentation that provides an overview of validation and discusses the need for validation, the validation process, and what it means to operate in a state of control.

This training package features a training presentation which provides training and quality professionals with a strong tool for training their workforce in the basics of post validation monitoring and validation lifecycle management.

This template package features a universal Quality Plan template with example text that can be integrated into any documentation system and used to define the quality practices, resources, and activities relevant to a process.

This training package features a training presentation which provides basic information on the writing and execution of validation protocols.

This template package features a universal traceability matrix template that provides a ready-to-populate document and spreadsheet to generate a trace matrix for any system validation.